Tag: pharmaceutical guidelines

Ensuring Adequacy of Process Controls for Granulation Stages

March 5, 2025 Admin

Ensuring Adequacy of Process Controls for Granulation Stages Ensuring Adequacy of Process Controls for Granulation Stages Introduction: Granulation is a critical process in the pharmaceutical industry, playing a pivotal role in the production of solid dosage forms such as tablets. It involves the aggregation of powder particles to form larger granules, which enhance the flow…

Solid Dosage form, Tablets

Preventing Over-Drying of Hygroscopic Tablets in Fluid Bed Dryers

March 5, 2025 Admin

Preventing Over-Drying of Hygroscopic Tablets in Fluid Bed Dryers Preventing Over-Drying of Hygroscopic Tablets in Fluid Bed Dryers Introduction: In the pharmaceutical industry, maintaining the integrity and efficacy of tablet formulations is of paramount importance. Hygroscopic tablets, known for their moisture-attracting properties, present unique challenges during the drying process. Fluid bed dryers, a common tool…

Solid Dosage form, Tablets

Troubleshooting Heat Sensitivity Issues During Fluid Bed Drying

March 5, 2025 Admin

Troubleshooting Heat Sensitivity Issues During Fluid Bed Drying Troubleshooting Heat Sensitivity Issues During Fluid Bed Drying Introduction: Fluid bed drying is a widely used method in pharmaceutical manufacturing for drying granules and powders before tablet compression. This process ensures uniform drying and improved product quality. However, the challenge of heat sensitivity in certain pharmaceutical compounds…

Solid Dosage form, Tablets

Addressing Non-Compliance in Utility Validation for Hygroscopic Tablet Production

March 5, 2025 Admin

Addressing Non-Compliance in Utility Validation for Hygroscopic Tablet Production Addressing Non-Compliance in Utility Validation for Hygroscopic Tablet Production Introduction: In the pharmaceutical industry, producing high-quality tablets that meet regulatory standards is crucial. Among various tablet forms, hygroscopic tablets present unique challenges due to their moisture sensitivity. Utility validation is a vital part of ensuring that…

Solid Dosage form, Tablets

Addressing High Friability in Sugar-Coated Tablets

March 4, 2025 Admin

Addressing High Friability in Sugar-Coated Tablets Addressing High Friability in Sugar-Coated Tablets Introduction: Sugar-coated tablets are a popular solid dosage form due to their appealing appearance, taste masking capabilities, and ability to protect the drug core from environmental factors. However, achieving the ideal balance between coating thickness and tablet robustness is crucial to maintain product…

Solid Dosage form, Tablets

Addressing Humidity Control Failures in Utility Validation for Film-Coated Tablets

March 4, 2025 Admin

Addressing Humidity Control Failures in Utility Validation for Film-Coated Tablets Addressing Humidity Control Failures in Utility Validation for Film-Coated Tablets Introduction: In the realm of pharmaceutical manufacturing, maintaining optimal environmental conditions is crucial to ensuring product quality and efficacy. One significant aspect is humidity control, especially when it comes to the production of film-coated tablets….

Solid Dosage form, Tablets

Challenges in validating water storage systems for microbial stability.

March 4, 2025 Admin

Challenges in validating water storage systems for microbial stability. Challenges in validating water storage systems for microbial stability. Introduction: Water is a critical utility in pharmaceutical manufacturing, playing a vital role in the production of solid oral dosage forms, including capsules. Ensuring the microbial stability of water storage systems is paramount to maintaining product quality…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Inadequate systems for detecting capsule discoloration under light exposure.

March 4, 2025 Admin

Inadequate systems for detecting capsule discoloration under light exposure. Inadequate systems for detecting capsule discoloration under light exposure. Introduction: Capsules, both hard and soft gelatin, are one of the most popular solid oral dosage forms in the pharmaceutical industry. However, they are not immune to challenges that can affect their quality and efficacy. One such…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Challenges in determining capsule degradation rates under UV light exposure.

March 4, 2025 Admin

Challenges in determining capsule degradation rates under UV light exposure. Challenges in determining capsule degradation rates under UV light exposure. Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of medications is paramount. Capsules, both hard and soft gelatin, are popular solid oral dosage forms due to their ease of use and patient compliance….

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets

March 4, 2025 Admin

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Introduction: In the pharmaceutical industry, the production of multi-layer tablets requires meticulous attention to detail to ensure product safety and efficacy. One critical aspect of tablet production is the use of fluid bed granulators, which…

Solid Dosage form, Tablets

Resolving Weight Variations in Tablets Stored in Variable Humidity Conditions

March 3, 2025 Admin

Resolving Weight Variations in Tablets Stored in Variable Humidity Conditions Resolving Weight Variations in Tablets Stored in Variable Humidity Conditions Introduction: In the pharmaceutical industry, ensuring the consistency and quality of tablets is paramount. One of the critical quality attributes is tablet weight, which can be significantly affected by environmental conditions, particularly humidity. Weight variations…

Solid Dosage form, Tablets

Managing Non-Uniform API Distribution in Content Uniformity Tests

March 3, 2025 Admin

Managing Non-Uniform API Distribution in Content Uniformity Tests Managing Non-Uniform API Distribution in Content Uniformity Tests Introduction: The uniform distribution of the Active Pharmaceutical Ingredient (API) in solid dosage forms, such as tablets, is a critical quality attribute in pharmaceutical manufacturing. The reliability of therapeutic outcomes and patient safety hinges on the consistent delivery of…

Solid Dosage form, Tablets